MAUDE Adverse Event Report: KAZ USA, INC BRAUN; THERMOMETER

Model Number IRT-4520

Device Problem Low Readings (2460)

Patient Problem No Code Available (3191)

Event Date 03/01/2014

Event Type  Other  

Event Description

A consumer reported that her thermometer had allegedly given a false negative reading.The device was reading in the low range despite their daughter having a fever.The child was seen by their doctor.There were no further complications and the pt is doing well now.Kaz was requested that the device be returned to our company for further investigation.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3784195
• MDR Text Key: 4378968
• Report Number: 1314800-2014-00036
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-4520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other